<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200115046147N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-01</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of magnesium supplements on  polycystic ovarian syndrome (PCOS)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of magnesium supplements on clinical and metabolic variables in women with polycystic ovarian syndrome (PCOS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45198</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced Block Randomization, Blinding description: Patients are treated with prescribed medication packages by the study supervisor (supervisor). The drug packages are quite similar in form and the patient and the planner are not aware of the contents of the packages. In addition, information is collected, the patients are evaluated and the forms are completed by the planner and his assistant who are not aware of the contents of the packages; The data analysis will also be performed by the design consultant and design consultant who is unaware of the contents of the drug packages and only the patient group (group 1 or 2) is identified to analyze the data, so the study is three-blind.</study_design>
      <phase>3</phase>
      <hc_freetext>polycystic ovarian syndrome (PCOS).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the magnesium group, magnesium oxide supplement made by Galen's company in the form of 250 mg a day for two months will be given to patients and in the control group only placebo produced by the same company with the same form of magnesium catabolic The patient will be prescribed daily. Intervention 2: Control group: In the control group, only placebo, manufactured by Galen's company, in the same form as magnesium chelate, will be administered daily to patients for two months.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more informations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shabnam Shahmoradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrak karmandan - Faz 2 - 5 Gharbi - pelak 621 - Vahed 9</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513966741</zip>
        <telephone>+98 24 3344 0932</telephone>
        <email>ashkanghadimi23@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shabnam Shahmoradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrak karmandan - Faz 2 - 5 Gharbi - pelak 621 - Vahed 9</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513966741</zip>
        <telephone>+98 24 3344 0932</telephone>
        <email>ashkanghadimi23@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Patients with polycystic ovary syndrome based on the Rotterdam Diagnostic Criteria2. Satisfaction with attending the study3. Satisfaction to continue cooperation4. Magnesium does not have a high base normal.5. There is no history of electrolyte abnormalities associated with potassium or calcium in the patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the magnesium group, magnesium oxide supplement made by Galen's company in the form of 250 mg a day for two months will be given to patients and in the control group only placebo produced by the same company with the same form of magnesium catabolic The patient will be prescribed daily.</i_keyword>
      <i_keyword>Control group: In the control group, only placebo, manufactured by Galen's company, in the same form as magnesium chelate, will be administered daily to patients for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in Insulin Resistance Index (HOMA-IR). Timepoint: FBS and serum insulin are re-administered to patients at baseline and after 2 months of treatment (end of treatment). Method of measurement: ice.Patients receive fasting insulin for a 12-hour fasting blood sample to measure fasting blood sugar (for diabetes screening).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight Loss and Blood Glucose and Lipid Profile and Blood Pressure and Menstrual Cycle Adjustment in Magnesium Supplemented Patients. Timepoint: After 2 months of treatment (end of treatment), weight, waist circumference, blood pressure, menstrual pattern and serum levels of FBS, TG, CHOL, LDL, HDL and insulin are monitored again for two months after completion. Patients will be monitored for clinical symptoms including menstruation, weight, waist circumference and blood pressure. Method of measurement: The pattern of menstrual periods is recorded in a questionnaire designed for the duration and duration of bleeding during the menstrual cycle. After fasting for 12 hours, a blood sample was taken to measure fasting blood sugar (for diabetes screening), fasting insulin and Mg levels, as well as TG, CHOL, HDL and LDL. People are included in the study who do not have high normal magnesium levels. Weight in fasting, without shoes, with minimal clothing and measured using the Seca Digital Balance with a accuracy of 0.1 kg. Height is measured with the help of a tape measure with a accuracy of 0.1 cm. BMI is calculated by dividing the weight in kilograms by the power of 2 heights per meter. Waist circumference greater than 5 cm above the navel and hip circumference less than 5 cm below the navel are measured with tape measure. Patients' blood pressure is measured and recorded with a single device.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-14</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Gavazang Road - Ayatollah Mousavi Hospital zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
